Kornimate/medical-research-clean huggingface dataset:
hypopituitarism after aneurismal subarachnoid hemorrhage

Conditions: Aneurismal Subarachnoid Hemorrhage; Hypopituitarism; Neuropsychological Deficits

Summary: introduction: almost 50% of patients die after aneurismal subarachnoid hemorrhage (asah). 30% of the survivors suffer from neurological handicap and need permanent care (suarez et al.). even when neurological outcome is good, neuropsychological deficits are frequently observed (ogden et al., anderson et al.) the incidence rate of asah is almost 8 of 100.000 per year. due to similar clinical symptoms to patients with hypopituitarism, several studies have analyzed the incidence of hypopituitarism after asah. dysfunction of the anterior pituitary gland was found in up to 47% (schneider et al.). gh deficiency was demonstrated in almost every fourth patient and an association with poor recovery was postulated. in germany, the investigators would therefore expect as many as 1200 patients with incident gh deficiency. the kims-study is an observational gh-treatment study in adult onset growth hormone deficiency. within the epidemiological data of kims, asah is not known as a relevant contributing cause (brabant et al.). this resembles much of the investigators clinical experience that there is no huge prevalence of hypopituitarism after asah. objective: evaluation of the frequency of hypopituitarism and neuropsychological dysfunction of any degree in patients with asah in a prospective approach. methods: the investigators conduct a prospective study for the evaluation of endocrine deficiency with asah. the investigators study patients 3, 6 and 12 month after aneurismal bleeding. patients diagnosed with asah with a clinical grade of i-iv according to hunt and hess are included in the study. the investigators perform basal testing for the pituitary by measuring: tsh, lh, fsh, igf-1, gh, prolactin and acth. for evaluation of the adrenal function the investigators perform an acth-stimulation test (lindholm et al.). subjects with evidence for adrenal or gh insufficiency are further analyzed by insulin-induced hypoglycemia testing (gh research society). in the neuropsychological examination, the investigators screen for verbal comprehension (token test, short form) and visual neglect (line bisection). verbal and visual short term memory (digit and spatial span), visuospatial construction and figural memory (rey osterrieth complex figure test), psychomotor speed, attention and concentration (trail making test part a and b, d2) as well as mental flexibility (word fluency) are assessed. patients additionally fill out a questionnaire measuring actual depressive symptoms and anxiety (hospital anxiety and depression scale).


Eligibility criteria:
inclusion criteria: * asah grade i-iv hunt und hess * bleeding cct fisher grade 3-4 * therapy within 48h after asah * preoperative angiography as well as control angiography * glasgow outcome scale 4 to 5 after therapy exclusion criteria: * known intra-, peri- or suprasellar neoplasia * preexisting hypopituitarism of any degree * previous hormonal substitution * previous radiation * for the neuropsychological examination: difficulties with german language
postoperative thrombosis prevention in patients with cd

Conditions: Cushing Disease; DVT; Pulmonary Embolism

Summary: patients with cushing disease was randomized to 2 groups. after surgery, the patients were managed with mechanical prevention or mechanical prevention plus anticoagulant drugs(lmwh followed by rivaroxaban), vte was observed 24h, 5day, 4weeks and 12weeks after surgery.bleeding events were also recorded.

cushing disease, caused by acth-secreting pituitary adenomas, can lead to serious complications with increased mortality. minimally invasive surgery is currently the preferred treatment for the disease, allowing more than 80% of tumors to be completely removed. however, postoperative venous thrombosis (vte), including deep vein thrombosis (dvt) and pulmonary embolism (pe) pose great threats to patients' safety. according to the literatures and the data from our center, up to 27% of the patients with cushing's disease developed vte after surgery. due to the lacking of a randomized prospective study, there is no consensus or guideline on preventative anticoagulation protocols for postoperative management in patients with cushing's disease. this is a prospective randomized control study on preventative anticoagulation in patients with cushing's disease after transsphenoidal resection.

Eligibility criteria:
inclusion criteria: * cushing\&#39;s disease diagnosed and treated with transsphenoid surgery at study centers exclusion criteria: 1. history of vte before surgery or within 24 hours post-surgery 2. acute bacterial endocarditis 3. major bleeding events 4. thrombocytopenia 5. active gastrointestinal ulcers 6. history of stroke 7. high risk of bleeding due to clotting abnormalities 8. participation in other clinical trials within the last three months 9. contraindications to rivaroxaban (e.g., renal dysfunction with egfr \&lt; 50 ml/min) 10. presence of other malignant diseases 11. severe mental or neurological disorders 12. presence of intracranial vascular abnormalities 13. contraindications to mechanical prophylactic anticoagulation 14. pregnancy 15. any other condition that researchers deem inappropriate for study participation.
paxil cr bioequivalence study

Conditions: Depressive Disorder

Summary: this study is to determine if controlled release paroxetine tablets manufactured at two different sites behave similarly in healthy volunteers.


Eligibility criteria:
key inclusion: healthy males or females between 18-65. body weight 50 kg (110 lbs) or higher, and bmi within the range 19-30 kg/m2. willing to use acceptable forms of birth control throughout the study. normal labs and ecg. key exclusion: positive test for drugs or alcohol. positive for hepatitis or hiv. any history of psychiatric disorder or suicidal behavior. has taken another investigational product within 30 days of the start of this study. has been exposed to more than 4 new chemical entities in the last 12 months. females who are pregnant or nursing. regular consumption of alcohol; \>14 drinks/week for men or \>7 drinks/week for women. heavy smokers; greater than 20 cigarettes per day.

Keywords: healthy volunteers paroxetine
persons with dementia and their extended family caregivers

Conditions: Dementia; Dementia Alzheimers; Neuro-Degenerative Disease; Dementia of Alzheimer Type; Dementia Severe

Summary: immediate family members shoulder the majority of care responsibilities for persons living with dementia. however, due to various societal changes, elder care responsibilities have expanded to extended family members, including grandchildren, siblings, nieces/nephews, siblings, and step-kin. the main objective of this study is to understand the caregiving journeys of various extended family members involved in dementia care. we aim to learn about caregivers' care management strategies; their use of home and community-based services and informal support; and barriers to service usage. we will use the results from the study to help enhance service delivery, alleviate care-related stress, and improve the quality of life of dementia patients and their caregivers. we will use a mixed-methods design to explore the challenges faced by caregivers as well as their service usage for the person living with dementia. our methodology involves an initial telephone interview (approx. 70 minutes) that includes open-ended questions, standard items, and structured measures, followed by an 8-day semi-structured daily diary interview about daily care responsibilities and experiences with services (15-20 minutes each evening). this study will be conducted with 240 extended family members serving as one of the main caregivers for a person living with dementia in a community setting.


Eligibility criteria:
inclusion criteria: * speaks/reads english * resident of virginia, north carolina, maryland, west virginia, tennessee, kentucky or washington, d.c. * age 18+ * is either the grandchild, sibling, niece/nephew, step-kin, adult child or spouse of the person living with dementia * is providing hands-on care and/or overall management of care for a person living with dementia in the community * caregiver co-resides with the person with dementia or has face-to-face contact with the person with dementia at least 3 days/week * has no difficulty talking/hearing on the telephone exclusion criteria: * caregiver of persons with mild cognitive impairment * person with dementia lives in service-enriched housing such as a continuing care community, or residential facilities, such as assisted living facilities or nursing homes

Keywords: caregiving, persons living with dementia, community-based services
water method in low-body mass index (bmi) female patients with unsedated colonoscopy

Conditions: Adenoma; Pain

Summary: water method with water exchange has been shown to reduce medication requirement and pain experienced during colonoscopy. it increases the success rate of cecal intubation in sedated and unsedated patients undergoing screening colonoscopy. exchange of water during scope insertion minimizes distension of the colonic lumen and decreases loop formation. exclusion of air from the colon during insertion by omission of air insufflations and suction removal of residual air prevent elongation of the colon. these maneuvers facilitate colonoscopy insertion in average patients and may enhance the success of difficult colonoscopy. female gender and low-body mass index (bmi) is independently associated with incomplete colonoscopy, respectively. the investigators postulate that low-bmi female patients may benefit from using the water method for colonoscopy. in this proposal the investigators test the hypothesis that compared with conventional air insufflations the water method with water exchange significantly enhances the success rate of cecal intubation in low-bmi female patients. the aim of the study is to compare the outcome of colonoscopy using the water method versus the conventional air method in low-bmi female patients. the primary outcome is cecal intubation success rate. the secondary outcomes include cecal intubation time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.


Eligibility criteria:
inclusion criteria: * female patients with bmi \< 20 exclusion criteria: * history of colorectal surgery * severe colonic stricture or obstructing tumor * patients who cannot give informed consent and those who are hemodynamically unstable

Keywords: colonoscopy water female bmi unsedated low bmi female patients intubation
empowering patients on choices for renal replacement therapy (aim 2)

Conditions: Chronic Kidney Disease

Summary: empowering patients on choices for renal replacement therapy (epoch-rrt) study seeks to identify factors that matter the most to patients with kidney disease and study how they are impacted by different types of dialysis. the inclusion of patients, caregivers, and patient advocacy organizations as research partners will assure that the study addresses questions of greatest relevance to patients facing the need for dialysis. aim two is based on preliminary results of aim one interviews, and in collaboration with the patient advisory panel, the investigators developed a brief questionnaire to be administered to participants in the dialysis outcomes and practice patterns study (dopps) and peritoneal dialysis outcomes and practice patterns study (pdopps). two separate versions of the questionnaire were created to reflect unique aspects of in-center hemodialysis (hd) and peritoneal dialysis (pd).


Eligibility criteria:
inclusion criteria: * individuals 18 years of age or older. * currently consented in the dialysis outcomes and practice patterns study - (dopps) or the peritoneal outcomes and practice patterns study (pdopps). exclusion criteria: * individuals under 18 years of age. * individuals unable to provide informed consent.

Keywords: chronic kidney disease hemodialysis peritoneal dialysis
drug-drug intercations and direct acting antiviral agents against hcv

Conditions: HCV Infection

Summary: background: currently used direct-acting antivirals (daa) share pharmacokinetic pathways with many comedications commonly used in patients with chronic hepatitis c virus (hcv) infection, therefore drug-drug interactions (ddi) might exist. although extensive (ddi) verification is recommended by most clinical practice guidelines, real-world studies have shown that approximately one-tenth of patients on daa therapy also take concomitant medication with the potential for significant interactions. despite the risk of significant ddi when patients are administered daa and a concomitant medication, to date, there is very little information on whether these interactions translate into changes in the toxicity or efficacy of any involved daa or comedication in clinical practice. clarifying this issue is a critical point, as the ddi profile of the currently used daa is not the same, with sof/vel showing a lower risk of significant ddi than gle/pib. thus the objective of this study is to compare the percentage of comedication switch, withdrawal, or dose reduction at treatment initiation and during treatment with gle/pib or sof/vel. methods: the patients will be enrolled from the gehep 001/hepavir cohort. "the hepavir-daa cohort (nct02057003)", includes hiv/hcv-coinfected patients, and "the gehep-mono cohort (nct02333292)", that includes hcv mono-infected individuals, are ongoing prospective multicenter cohorts of patients receiving daa combinations prescribed in clinical practice, outside clinical trials. main study end point will be the frequency of comedication switch, withdrawal or dose reduction at treatment initiation (index date) and during treatment with gle/pib or sof/vel.


Eligibility criteria:
inclusion criteria: 1. treatment naive patients who received therapy with gle/pib or sof/vel between april 1st, 2018, and july 1st, 2023, receiving ≥ 1 comedication or recreational drug. 2. attended in a hospital with electronic clinical records allowing access to all clinical visits and prescribed medications, both in all hospitals and in primary care institutions of the corresponding spanish region during the study period. exclusion criteria: patients who meet any of the following criteria will be excluded from the study: 1. hcv treatment-experienced patients will be excluded. 2. patients without any comedication or recreational drug use 3. those who have attended private health care

Keywords: hcv sof/vel gle/pib drug-drug interactions
improving dental floss adherence and gingival health with sms and an innovative floss holder

Conditions: Behavior; Gingivitis

Summary: this study proposes to evaluate the effects of using a new floss holder (gumchuck) and the use of text messages during supportive periodontal therapy, on the psychological, behavioral and clinical parameters of patients with gingivitis, outlined by evidence and a theory-based framework.

despite evidence on the benefits of controlling dental biofilm for preventing gingivitis, patients have difficulty complying. floss holder devices and sms may be useful in enhancing both the frequency and effectiveness of dental hygiene behaviors, by increasing patients' motivation and self-regulation efforts, but scarce scientific literature supporting their worth in controlling gingivitis and the underlying psychological processes is currently available.

Eligibility criteria:
inclusion criteria: * gingivitis bomp \> 0.5 * 20 teeth (minimum 5 per quadrant) * \> 18 years old exclusion criteria: * periodontitis (pockets \>3), * smoking, * orthodontics, * pregnancy * removable partial dentures

Keywords: gingivitis sms dental floss behavior change hapa
clevidipine in neurocritical patients

Conditions: High Blood Pressure

Summary: acute blood pressure elevation is a frequent problem in neurocritical patients. its effective management is challenging and must avoid significant decreases of blood pressure leading to lower cerebral perfusion pressure worsening ischemia and elevations probably associated with bleeding, rebleeding or hematoma expansion associated with poor prognosis

retrospective, observational and single-group study for observe effectiveness and safety of clevidipine for perioperative control of hypertension in patients admitted to post-operative intensive care unit after thrombectomy for stroke, intracerebral hemorrhage requiring surgical treatment, embolization of aneurysm after subarachnoid hemorrhage, scheduled neurosurgical and neuroradiology procedures.

Eligibility criteria:
inclusion criteria: 1. -adult patients older than 18 years old admitted to post-operative intensive care unit with neurocritical condition requiring surgical or interventional treatment. 2. -acute high blood pressure requiring urgent treatment (sbp ≥160 mmhg or ≥ 20% increase in preoperative values that persists for more than 15 minutes) 3. -clevidipine used as a first line or after failure of different antihypertensive drugs. exclusion criteria: 1. -adults older than 90 years admitted to post-operative intensive care unit with neurocritical condition requiring surgical or interventional treatment. 2. -patients admitted to post-operative intensive care unit with neurocritical condition not requiring surgical or interventional treatment.

Keywords: clevidipine neurocritical
correlation between markers of neuronal injury and cognitive dysfunction after coronary artery bypass surgery

Conditions: Postoperative Cognitive Dysfunction

Summary: this study aims to evaluate the possible correlation between serum levels of markers of neuronal injury and cognitive dysfunction after coronary artery bypass surgery.

the systemic inflammatory response after cardiac surgery may cause damage to the central nervous system and elevated markers of brain injury in peripheral blood. this event may be potentially related to the development of postoperative cognitive dysfunction (pocd), with incidences varying from 20 to 83%.

Eligibility criteria:
inclusion criteria: * patients underwent for coronary artery bypass graft surgery exclusion criteria: * history of brain disease or dementia, other psychiatric disorders that affect cognition * lack of proficiency in portuguese language

Keywords: postoperative cognitive dysfunction cardiac surgery general anesthesia neuropsychological tests
assessment of preoperative and postoperative ankle kinematics

Conditions: Ankle Osteoarthritis

Summary: the objective is to study the joint kinematics of the prosthetic implant, in terms of translation, rotation, range of motion and proprioception, in patients treated for prosthetic replacement of the ankle, quantitatively and under physiological load conditions.

patients will be subjected to the same tests at zero time and 9 months after the implantation of the prosthesis, except for rsa which will be performed only 9 months after the surgery.

Eligibility criteria:
inclusion criteria: * candidates for ankle prosthesis * potential party able to provide informed consent and sign the approved informed consent form; * male or female patients aged 40 to 80; * patients available to perform post-operative rehabilitation according to standard protocol, follow-up visits and radiological investigations scheduled for follow-up up up up to 24 months. in addition, patients who are available to perform all study tests, preoperators and follow-up. exclusion criteria: * previous total prosthetic replacement of the ankle (revision surgery); * severe pre-operative deformity in valgus or varus (\>10 sanguine); bmi\>40 kg/m2; * pre-existing abnormalities of walking kinematics (amputations, neuro-muscular diseases, polio, hip dysplasia); * severe arthrosis of the knee (kellgren-lawrence\>3); * severa coxartrosi (kellgren-lawrence\>3); * previous hip and/or knee prosthesis surgery; * total avascular astragalus necrosis or other severe bone loss of the ankle that makes the implantation of standard prosthetic components contraindicated; * pregnancy confirmed by positive hcg serum or in vitro diagnostic test or ongoing breastfeeding; * active or latent infection of the affected ankle joint or any other systemic infection being treated; * history of alcoholism, drug or substance abuse intravenously, psychosis, personality disorder/s, poor motivation, emotional or intellectual problems that could make the potential subject unstable for participation in the trial, or any combination of variables which in the opinion of the principal investigator should exclude the potential subject; * clinically documented acute or chronic pathology, other than the indication for the treatment adopted in this trial, which could affect life expectancy or make it difficult to interpret the outcome of the potential subject in accordance with the protocol (e.g., renal, hepatic, cardiac, endocrine, haematological, autoimmune, bone metabolism, crystal deposits or neoplasms); * potential subjects with medical conditions that interfere with the ability to participate in a standardized rehabilitation program; * participation in any other trial of another drug or experimental device within 60 days prior to the screening visit or administration of that drug or device during the course of this trial.

Keywords: ankle ostearthritis ankle prosthesis roentgen stereophotogrammetric analysis
effectiveness and clinical outcomes of long-term bulevirtide monotherapy in patients with hdv-related compensated cirrhosis

Conditions: Hepatitis D

Summary: retrospective and prospective, pharmacological, multicentre, non-profit observational study. consecutive patients with hdv-related compensated cirrhosis starting bulevirtide 2 mg/day from september 2019 to december 2025 will be enrolled in the study. aim of this study is to investigate virological and clinical effectiveness of bulevirtide 2 mg/day in patients with hdv-related compensated cirrhosis in the real-life setting. primary endpoint of the study is the rate of virological response, defined as at least 2 log decline or undetectable hdv rna compared to baseline, at week 96 of treatment.


Eligibility criteria:
inclusion criteria: * age≥18 years * hdv-related compensated cirrhosis defined by positivity of hdv rna for at least 6 months and clinical or laboratory or histological diagnosis of cirrhosis * started treatment with blv monotherapy between september 1st 2019 and 2025 exclusion criteria: * chronic hepatitis without any evidence of cirrhosis * decompensated cirrhosis * pegifn alpha therapy